Feasibility of Peer-mentor Delivered Substance Use Brief Intervention for Adolescents in Kenya
NCT ID: NCT05545904
Last Updated: 2022-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-01-15
2024-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans
NCT00792519
Youth Substance Use Prevention/Reduction Through Science-based Drug Abuse Education
NCT00612482
A Stage 2 Cognitive-behavioral Trial: Reduce Alcohol First in Kenya Intervention
NCT01503255
An App to Reduce Cannabis Use Among Emerging Adults
NCT05824754
The Peer-Based Retention of People Who Use Drugs in Rural Research
NCT03885024
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Objective: The aim of this study is to pilot study procedures and obtain data on intervention acceptability, fidelity and preliminary efficacy, to determine the feasibility of a definitive randomized controlled trial (RCT) of the efficacy of a peer-delivered substance use SBI among adolescents attending an out-patient clinic in Kenya.
Design: The study will use both qualitative and quantitative methods to meet its objectives
Intervention: SBI includes a single session of screening using the Alcohol, Smoking \& Substance Use Involvement Screening Test for Youth questionnaire (ASSIST-Y), followed by a brief intervention (20-30 minutes of motivational interviewing) for those with moderate and high risk substance use. Three peers will be trained for five days on how to deliver the SBI. The peer-mentors will receive regular supervision throughout the study implementation process.
Outcomes: SBI feasibility will be defined by the extent to which fidelity to the SBI is maintained and the preliminary effects of the SBI on substance use and quality of life outcomes. SBI acceptability will be evaluated from the perspective of the adolescents using qualitative interviews guided by Sekhon's theoretical framework of acceptability. Feasibility of conducting a future full-scale RCT will be explored by measuring outcomes such as study participation rate, willingness to be randomized, study completion rates and ability to measure effectiveness outcomes.
Investigating team and future plans: This study will be conducted by a team including faculty from Moi Teaching and Referral Hospital, faculty from Indiana University, and a team from the National Authority for Campaign Against Alcohol and drug abuse (NACADA). Our team has experience implementing and scaling peer-led substance use SBIs for adolescent populations. If the SBI and its delivery are found to be feasible and acceptable the plan is to partner with the government to conduct a full-scale multi-site RCT in Kenya and Indiana.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention arm
Participants randomized to the intervention arm will undergo a substance use screening and brief intervention delivered by the peer-mentors. Screening will be performed using the ASSIST-Y (28). The brief intervention will be delivered in a single session (20-30 minutes) using the FRAMES model i.e.(i) providing feedback on screening results (ii) ensuring responsibility on the part of the adolescents (iii) giving clear advice to stop/cut down (iv) giving menu of options (alternative healthy behaviors to engage in) (v) expressing empathy, and (vi) encouraging self-efficacy (15). The BI will be delivered for the highest scoring substance or the one the adolescent identifies as the most problematic.
Substance use brief intervention (BI)
The BI will be delivered in a single session (20-30 minutes) using motivational interviewing techniques and the FRAMES model i.e.(i) providing feedback on screening results (ii) ensuring responsibility on the part of the adolescents (iii) giving clear advice to stop/cut down (iv) giving menu of options (alternative healthy behaviors to engage in) (v) expressing empathy, and (vi) encouraging self-efficacy (15). The BI will be delivered for the highest scoring substance or the one the adolescent identifies as the most problematic.
Control arm
Participants assigned to the control arm will participate in a substance use education intervention. This intervention will entail review of material in the NACADA substance use education manual for adolescents, and will be followed by a question and answer session. The manual contains summarized and simple information on the harms and myths related to alcohol, tobacco, cannabis, prescription medication and khat use, substances. This education intervention will be delivered over a single 20-30 minute session by a counselor stationed at Rafiki clinic.
substance use education intervention
This intervention will entail review of material in the NACADA substance use education manual for adolescents, and will be followed by a question and answer session. The manual contains summarized and simple information on the harms and myths related to alcohol, tobacco, cannabis, prescription medication and khat use, substances. This education intervention will be delivered over a single 20-30 minute session by a counselor stationed at Rafiki clinic.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Substance use brief intervention (BI)
The BI will be delivered in a single session (20-30 minutes) using motivational interviewing techniques and the FRAMES model i.e.(i) providing feedback on screening results (ii) ensuring responsibility on the part of the adolescents (iii) giving clear advice to stop/cut down (iv) giving menu of options (alternative healthy behaviors to engage in) (v) expressing empathy, and (vi) encouraging self-efficacy (15). The BI will be delivered for the highest scoring substance or the one the adolescent identifies as the most problematic.
substance use education intervention
This intervention will entail review of material in the NACADA substance use education manual for adolescents, and will be followed by a question and answer session. The manual contains summarized and simple information on the harms and myths related to alcohol, tobacco, cannabis, prescription medication and khat use, substances. This education intervention will be delivered over a single 20-30 minute session by a counselor stationed at Rafiki clinic.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
15 Years
24 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Indiana University
OTHER
Moi University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
FLORENCE M, JAGUGA, MMED
Role: PRINCIPAL_INVESTIGATOR
MOI TEACHING & REFERRAL HOSPITAL
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Florence Jaguga
Eldoret, RIFT Valley, Kenya
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Peltzer K, Matseke G, Azwihangwisi M. Evaluation of alcohol screening and brief intervention in routine practice of primary care nurses in Vhembe district, South Africa. Croat Med J. 2008 Jun;49(3):392-401. doi: 10.3325/cmj.2008.3.392.
Winn LAP, Paquette KL, Donegan LRW, Wilkey CM, Ferreira KN. Enhancing adolescent SBIRT with a peer-delivered intervention: An implementation study. J Subst Abuse Treat. 2019 Aug;103:14-22. doi: 10.1016/j.jsat.2019.05.009. Epub 2019 May 14.
Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
Degenhardt L, Stockings E, Patton G, Hall WD, Lynskey M. The increasing global health priority of substance use in young people. Lancet Psychiatry. 2016 Mar;3(3):251-64. doi: 10.1016/S2215-0366(15)00508-8. Epub 2016 Feb 18.
National Institute of Drug Abuse. Principles of Adolescent Substance Use Disorder Treatment: A Research-Based Guide: Introduction | NIDA [Internet]. [cited 2022 Feb 27]. Available from: https://nida.nih.gov/publications/principles-adolescent-substance-use-disorder-treatment-research-based-guide/introduction
Heradstveit O, Skogen JC, Hetland J, Hysing M. Alcohol and Illicit Drug Use Are Important Factors for School-Related Problems among Adolescents. Front Psychol. 2017 Jun 20;8:1023. doi: 10.3389/fpsyg.2017.01023. eCollection 2017.
Ritchwood TD, Ford H, DeCoster J, Sutton M, Lochman JE. Risky Sexual Behavior and Substance Use among Adolescents: A Meta-analysis. Child Youth Serv Rev. 2015 May;52:74-88. doi: 10.1016/j.childyouth.2015.03.005.
Gaitho D, Kumar M, Wamalwa D, Wambua GN, Nduati R. Understanding mental health difficulties and associated psychosocial outcomes in adolescents in the HIV clinic at Kenyatta National Hospital, Kenya. Ann Gen Psychiatry. 2018 Jul 10;17:29. doi: 10.1186/s12991-018-0200-8. eCollection 2018.
Lisdahl KM, Gilbart ER, Wright NE, Shollenbarger S. Dare to delay? The impacts of adolescent alcohol and marijuana use onset on cognition, brain structure, and function. Front Psychiatry. 2013 Jul 1;4:53. doi: 10.3389/fpsyt.2013.00053. eCollection 2013.
Erskine HE, Moffitt TE, Copeland WE, Costello EJ, Ferrari AJ, Patton G, Degenhardt L, Vos T, Whiteford HA, Scott JG. A heavy burden on young minds: the global burden of mental and substance use disorders in children and youth. Psychol Med. 2015 May;45(7):1551-63. doi: 10.1017/S0033291714002888. Epub 2014 Dec 23.
Richmond-Rakerd LS, Slutske WS, Wood PK. Age of initiation and substance use progression: A multivariate latent growth analysis. Psychol Addict Behav. 2017 Sep;31(6):664-675. doi: 10.1037/adb0000304. Epub 2017 Aug 14.
Zewdu S, Hanlon C, Fekadu A, Medhin G, Teferra S. Treatment gap, help-seeking, stigma and magnitude of alcohol use disorder in rural Ethiopia. Subst Abuse Treat Prev Policy. 2019 Jan 18;14(1):4. doi: 10.1186/s13011-019-0192-7.
Jaguga F, Kwobah E. A review of the public sector substance use disorder treatment and prevention systems in Kenya. Subst Abuse Treat Prev Policy. 2020 Jul 20;15(1):47. doi: 10.1186/s13011-020-00291-5.
Hoeft TJ, Fortney JC, Patel V, Unutzer J. Task-Sharing Approaches to Improve Mental Health Care in Rural and Other Low-Resource Settings: A Systematic Review. J Rural Health. 2018 Dec;34(1):48-62. doi: 10.1111/jrh.12229. Epub 2017 Jan 13.
World Health Organisation. Brief Intervention. A Manual For Use In A Manual For Use In A Manual For Use In A Manual For Use In Primary Care Primary. 2003.
United Nations Office on drugs and Crime. International standards on drug use prevention - second updated edition [Internet]. 2018. 58 p. Available from: http://www.unodc.org/documents/prevention/standards_180412.pdf
Harris SK, Csemy L, Sherritt L, Starostova O, Van Hook S, Johnson J, Boulter S, Brooks T, Carey P, Kossack R, Kulig JW, Van Vranken N, Knight JR. Computer-facilitated substance use screening and brief advice for teens in primary care: an international trial. Pediatrics. 2012 Jun;129(6):1072-82. doi: 10.1542/peds.2011-1624. Epub 2012 May 7.
Winters KC, Lee S, Botzet A, Fahnhorst T, Nicholson A. One-year outcomes and mediators of a brief intervention for drug abusing adolescents. Psychol Addict Behav. 2014 Jun;28(2):464-474. doi: 10.1037/a0035041.
Carney T, Johnson K, Carrico A, Myers B. Acceptability and feasibility of a brief substance use intervention for adolescents in Cape Town, South Africa: A pilot study. Int J Psychol. 2020 Dec;55(6):1016-1025. doi: 10.1002/ijop.12668. Epub 2020 Apr 13.
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
Humeniuk R, Ali R, Babor TF, Farrell M, Formigoni ML, Jittiwutikarn J, de Lacerda RB, Ling W, Marsden J, Monteiro M, Nhiwatiwa S, Pal H, Poznyak V, Simon S. Validation of the Alcohol, Smoking And Substance Involvement Screening Test (ASSIST). Addiction. 2008 Jun;103(6):1039-47. doi: 10.1111/j.1360-0443.2007.02114.x. Epub 2008 Mar 28.
Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
Osborn TL, Venturo-Conerly KE, Wasil AR, Schleider JL, Weisz JR. Depression and Anxiety Symptoms, Social Support, and Demographic Factors Among Kenyan High School Students. J Child Fam Stud [Internet]. 2020 May 1 [cited 2020 Oct 22];29(5):1432-43. Available from: https://link.springer.com/article/10.1007/s10826-019-01646-8
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Musyoka CM, Mbwayo A, Donovan D, Mathai M. Alcohol and substance use among first-year students at the University of Nairobi, Kenya: Prevalence and patterns. PLoS One. 2020 Aug 28;15(8):e0238170. doi: 10.1371/journal.pone.0238170. eCollection 2020.
Gamarel KE, Brown L, Kahler CW, Fernandez MI, Bruce D, Nichols S; Adolescent Medicine Trials Network for HIV/AIDS Intervention. Prevalence and correlates of substance use among youth living with HIV in clinical settings. Drug Alcohol Depend. 2016 Dec 1;169:11-18. doi: 10.1016/j.drugalcdep.2016.10.002. Epub 2016 Oct 11.
Atwoli L, Mungla PA, Ndung'u MN, Kinoti KC, Ogot EM. Prevalence of substance use among college students in Eldoret, western Kenya. BMC Psychiatry. 2011 Feb 28;11:34. doi: 10.1186/1471-244X-11-34.
Hogue A, Henderson CE, Ozechowski TJ, Robbins MS. Evidence base on outpatient behavioral treatments for adolescent substance use: updates and recommendations 2007-2013. J Clin Child Adolesc Psychol. 2014;43(5):695-720. doi: 10.1080/15374416.2014.915550. Epub 2014 Jun 13.
Hogue A, Henderson CE, Becker SJ, Knight DK. Evidence Base on Outpatient Behavioral Treatments for Adolescent Substance Use, 2014-2017: Outcomes, Treatment Delivery, and Promising Horizons. J Clin Child Adolesc Psychol. 2018 Jul-Aug;47(4):499-526. doi: 10.1080/15374416.2018.1466307. Epub 2018 Jun 12.
World Health Organization (WHO). Optimal Mix of Health Services. 2007; Available from: https://www.who.int/mental_health/policy/services/2_Optimal Mix of Services_Infosheet.pdf
Aalsma MC, Dir AL, Zapolski TCB, Hulvershorn LA, Monahan PO, Saldana L, Adams ZW. Implementing risk stratification to the treatment of adolescent substance use among youth involved in the juvenile justice system: protocol of a hybrid type I trial. Addict Sci Clin Pract. 2019 Sep 6;14(1):36. doi: 10.1186/s13722-019-0161-5.
Aalsma MC, Aarons GA, Adams ZW, Alton MD, Boustani M, Dir AL, Embi PJ, Grannis S, Hulvershorn LA, Huntsinger D, Lewis CC, Monahan P, Saldana L, Schwartz K, Simon KI, Terry N, Wiehe SE, Zapolski TCB. Alliances to disseminate addiction prevention and treatment (ADAPT): A statewide learning health system to reduce substance use among justice-involved youth in rural communities. J Subst Abuse Treat. 2021 Sep;128:108368. doi: 10.1016/j.jsat.2021.108368. Epub 2021 Mar 16.
Skevington SM, Dehner S, Gillison FB, McGrath EJ, Lovell CR. How appropriate is the WHOQOL-BREF for assessing the quality of life of adolescents? Psychol Health. 2014;29(3):297-317. doi: 10.1080/08870446.2013.845668. Epub 2013 Nov 6.
Jaguga F, Aalsma MC, Enane LA, Turissini M, Kwobah EK, Apondi E, Barasa J, Kosgei G, Olando Y, Ott MA. A qualitative pilot study exploring the acceptability of a peer provider delivered substance use brief intervention from the perspective of youth in Kenya. Subst Abuse Treat Prev Policy. 2025 Feb 11;20(1):6. doi: 10.1186/s13011-025-00639-9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MoiU6
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.